Job Title: Sr. Clinical Scientist / Associate DirectorLocation: Marlborough, MAResponsibilitiesWork within a matrix environment to proactively coordinate understanding of priorities and deliverables throughout study conductProvide clinical input for and participate in study set up and design including data collection tools, data analysis, eCRF design, edit checks, vendor database design plans, etc.Review and provide input for the design of the Statistical Analysis Plan, TLFs, and the clinical data outputStudy-level efficacy and safety data review and interpretation, including documentation and summarization of findings for Sr. Clinical Research or cross-functional staff and proper escalation of any identified issuesClinical/medical review of site-level and subject-level data, including safety data, efficacy data, protocol deviations and codingLead and/or support the preparation of clinical/regulatory documents as required, such as protocols and protocol amendments, CSRs, Investigator's brochure, and responses to health authoritiesAnswer clinical (safety & protocol) questions directly from sites or from the site monitorAnswer specific inclusion/exclusion criteria questions and participate in subject eligibility reviewConduct literature review and critical analysis as well as regulatory guidance review and summarizationSkills:Must have minimum 5+ years pharma experience in clinical scientist/clinician/monitoring/CRA or related rolesHas comprehensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience and/or education in the clinical research fieldPsychiatry or Neurology TA area experience strongly preferredHas ability to work independently with instruction primarily on unusual or complex problemsHas working knowledge of statistics, data analysis, and data interpretationHas exceptional written and oral communication and cross-functional collaborative skillsExperience in in all aspects of clinical trials, Google Cloud Platform, and evaluation of adverse events and data reviewThorough knowledge of the investigational product(s), the protocol, applicable SOPs, Google Cloud Platform, data privacy laws and local regulatory requirementsIs proficient in MS Word, Excel, and PowerPointMS Degree in science or health-related field and extensive relevant experience requiredMD or DO, or PhD or Pharm D preferredRequired Skills:CLINICAL RESEARCH,CLINICAL TRIALS,CRA,DATA ANALYSIS,DATA COLLECTION,DATABASE,DATABASE DESIGN,Google Cloud Platform,REGULATORY DOCUMENTS,SOPS,STATISTICAL ANALYSIS
